Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874223
• Other study ID #: 23346
• Status: Completed
• Start date: June 2013
• Est. completion date: November 4, 2018

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related QOL questionnaire scores will correlate with physiologic markers of IPF severity and worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are important to assess the benefit of investigational drugs under development to treat patients with IPF.

Description:

This study in patients with IPF will determine the validity, responsiveness, and reliability of two cough measures (the Leicester Cough Questionnaire (LCQ), as well as Visual Analogue Scales (VASs) for cough severity and distress; one dyspnea measure (the Baseline and Transition Dyspnea Index (BDI/TDI); and two health-related quality of life (HRQL) measures (the obstructive lung disease-specific Saint George's Respiratory Questionnaire (SGRQ) and the IPF-specific 'A Tool to Assess QOL in IPF' (ATAQ-IPF). Both the SGRQ and ATAQ include cough questions. Study participants will complete all questionnaires at baseline, 6, 12, and 18 months at the time of their usual clinic visits. Physiologic data will be collected at the same time of these visits including pulmonary function testing, exercise oxygen saturation, and changes in medications and health status. Changes in cough, dyspnea and QOL scores will be correlated with concurrent changes in physiologic markers of IPF severity. If a study participant has an acute worsening of their IPF, or undergoes lung transplantation, study questionnaires may be given at these additional timepoints when possible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of informed consent.
• Adults over the age of 18.
• Diagnosis of IPF per ATS guidelines.
• Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation.
• No changes in immunosuppressive regimens (if applicable) over past month.

Exclusion Criteria:

• Inability to understand or complete paper and pencil questionnaires.
• Patient not planning to return to Stanford for clinic visits.

Related Conditions & MeSH terms

• Dyspnea
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Locations

Country	Name	City	State
United States	Stanford University Medical Center, Chest Clinic	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of LCQ scores with physiologic markers of IPF severity	Change scores for the LCQ cough-related quality of life instrument will be correlated with changes in pulmonary function tests	Baseline, 6, 12 and 18 months